Halyard 13543Recalls & reported problems
Avanos Medical, Inc. · HALYARD* Disposable Fluid Tunnelers & Sheaths 11 GA x 12 in · Class 2
All models of Halyard (232)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651135435), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: VIDEO ASSISTED THORACOSCOPY WITH TRUITT PLACEMENT. CATHPLACE: INTERCOSTAL REGION. IT WAS REPORTED AN INCIDENT THAT OCCURRED DURING AN ULTRASOUND ASSISTED PLACEMENT OF A CONTINUOUS INTERCOSTAL NERVE BLOCK FOR PAIN MANAGEMENT DUE TO FRACTURED RIBS. DURING THE PROCEDURE THE SURGEON "FULLY SEATED" THE TUNNELER DEVICE TOWARDS THE SCAPULA. THE TUNNELER WAS THEN REMOVED LEAVING THE T-PEEL SHEATH IN PLACE. THE SURGEON THEN BEGAN TO THREAD THE CATHETER INTO THE T-PEEL SHEATH WHEN BRIGHT RED BLOOD WAS NOTED TO BE COMING FROM THE TUNNELERS INSERTION SIGHT. THE CLINICIANS IDENTIFIED SOMETHING WAS WRONG AND CALLED FOR ASSISTANCE. THE PATIENT WAS "CODED" AND HAD TO UNDERGO AN "OPEN CHEST PROCEDURE". AFTER 2-HOURS, THE PATIENT WAS STABILIZED AND BROUGHT TO THE RECOVERY ROOM. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available
MAUDE report 9218754 ↗
Other PUMP, INFUSION, ELASTOMERIC devices
- EASYPUMP 4540018-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC313 reports
- Halyard 13568Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC86 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Avanos Medical, Inc. · Pump, infusion, elastomeric73 reports
- Halyard 13472Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC68 reports
- EASYPUMP 4540008-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC54 reports
- DOSI-FUSER L25915-600D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-500D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- Halyard 13561Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC42 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page